Ultragenyx Pharmaceutical files an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders.
CDERs Office of Prescription Drug Promotion says a CooperSurgical TV spot for ParaGard is misleading because it doesnt give risk information.
FDA approves Mercks Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus who...
FDA publishes a final guidance with information on the design of an appropriate nonclinical program for developing oncology therapeutic radiopharmaceu...
Federal Register notice: FDA establishes the prescription drug user fee rates for fiscal year 2020.
FDA grants B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous transluminal coronary...
FDA and the European Medicines Agency publish the report on a 2018 joint workshop on quality development in drug early access approaches.
Federal Register notice: FDA seeks comments on an information collection extension for medical device GMP regulation.